The present invention relates to devices for controlling urinary incontinence and vaginal and rectal prolapse in females. Particularly, the invention relates to a device which may be removably inserted into the vagina.
Female urinary incontinence is a common problem and is particularly prevalent where damage to the bladder or neck of the bladder has occurred during child birth. In elderly female patients, urinary incontinence is wide spread.
In normal continent patients, in the erect posture, there is no descent of the bladder neck below the pelvic floor muscle, thereby equal distribution of intra-abdominal pressure to the bladder and bladder neck and pelvic urethra occurs and continence is maintained. However, in stress incontinence this is lost due to descent of the bladder neck below the pelvic floor muscle. On coughing or sneezing or physical exercise, i.e. when strain is put upon the bladder, an involuntary spurt of urine is released from the bladder. This involuntary urine release is unpleasant and embarrassing. The released urine may irritate the groin region and result in an offensive odour.
Vaginal and rectal prolapse are quite common conditions in females, particularly those who have vaginally delivered one or more children. These conditions may be painful, and uncomfortable. Additionally, sexual intercourse may be impaired by occlusion of the vagina.
It is a generally accepted view that surgical treatment is most appropriate for cure of stress incontinence and vaginal and rectal prolapse. However, in elderly or infirm patients the risk of surgery is too great, so that often these conditions go untreated.
Previously proposed devices to treat incontinence and avoid recourse to surgery have generally been unsatisfactory. Particularly, they are cumbersome, difficult to use, need to be replaced frequently, are inadequate in cases of permanent incontinence and often fail to prevent involuntary urinary leakage.
A previously known intra-vaginal device for controlling urinary incontinence in females is disclosed in U.S. Pat. No. 4,139,006. This previously known device has as its object the deflection of the urethra. More particularly it has the object of displacing a surface of the superior wall of the vagina and intermediate sections of the urethra adjacent thereto, toward the pubic bone, to reduce the urethro-visicle angle to restore the patient's natural control over the flow of urine through the urethra from the bladder to the urethral opening. The device has a pair of forward projections which lie on either side of urethra intermediate portion and apply a force thereto to deflect the intermediate portion of the urethra towards the pubic bone.
Another known intra-vaginal device is disclosed in European Patent Specification No. 0 264 258 filed in the name of the present applicant. In this specification there is described a generally U-shaped device having a pair of resilient opposed limbs connected by a flexible base portion so that one of the limbs lies adjacent the posterior vaginal wall and the other limb, which is provided with a cradle-like structure for lifting the bladder base and neck, lies adjacent the anterior vaginal wall, the resiliency of the base portion being such as to bias the two limbs apart and into engagement with the walls of the vagina. Clearly, however, such devices which bias against the wall of the vagina can cause pain or irritation to the vaginal wall and, in order to mitigate this, must be very carefully matched in size to the vagina of the patient concerned. This is both costly and time consuming.
In a still further known intra-vaginal device for controlling urinary incontinence, as described in PCT Patent Specification No. WO 89/09582, also filed by the present applicant, there is proposed a substantially cup-shaped annulus of resilient material having a pair of rearwardly-extending, vaginal wall-engaging projections and a pair of forwardly and upwardly extending projections defining a cradle therebetween for receiving the bladder neck. Although the annulus can be made to be either planar or cup-shaped, the annulus must be sufficiently resilient to be deformed within the vagina into a cup-shape. Thus, once again, the vaginal walls must bias the device at a few discrete points of engagement, which can cause pain or irritation.